Surgical product supply system and method

ABSTRACT

A surgical product supply system includes a cart having a first compartment and a second compartment. The first compartment has first, second, third and fourth walls. The first and second walls are constructed of radio-reflective material and the third and fourth walls are constructed of a radio-absorptive material. The first compartment has a first storage area. A first RFID antenna array is attached to the first wall and is positioned within the first storage area. The first RFID antenna array includes a first plurality of RFID antennas. A second RFID antenna array is attached to the second wall and is positioned within the first storage area. The second RFID antenna array includes a second plurality of RFID antennas. The first RFID antenna is offset relative to the second RFID antenna such that opposing central axes of the first and second RFID antennas are not colinear.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/951,045, filed Nov. 18, 2020 and titled, “Surgical ProductSupply System and Method,” which is a continuation of U.S. patentapplication Ser. No. 16/620,687, filed Dec. 9, 2019, now U.S. Pat. No.10,878,953, and titled, “Surgical Product Supply System and Method,”which is a Section 371 of International Application No.PCT/US/2018/059965, filed Nov. 9, 2018, which was published in theEnglish language on May 16, 2019 under International Publication No. WO2019/094683 and claims the benefit of U.S. Provisional PatentApplication No. 62/583,638, filed Nov. 9, 2017 and titled “SurgicalProduct Supply System and Method” the entire contents of which areincorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

Many general surgical instruments and implant devices, and morespecifically those used in orthopedic surgery, have long been providedby medical device manufacturers in a steam-sterilizable or autoclavablecontainer. The surgical instruments and implant devices are typicallyhand-delivered to a surgical facility by a representative of the devicemanufacturer in the container or tray. Prior to the surgical procedure,the hospital or surgery center autoclaves or steam sterilizes the entiretray or container and its contents to sterilize the contents inpreparation for use on the patient. This process has inefficiencies ofboth time and money to all involved parties, and potential disruptionsassociated with the sterilization and delivery processes of theseproducts to the operating room, as well as their use during the surgicalprocedure.

These efforts can be inefficient and costly in terms of time, money andpotential risk for medical device companies and healthcare providers.Efforts to address these issues have been recently introduced in themedical marketplace in limited fashion through the use ofpre-sterilized, packaged surgical implants, and to a somewhat lesserextent, associated surgical instruments. For example, kits of sterilecomponents are being introduced such that sets of procedure-specificsterile implants and instruments are assembled for delivery to theoperating room. These kits are, however, application specific, limitedin scope, and cannot address unforeseen circumstances that may requireadditional types of implants and/or instruments beyond those provided,nor can they support cases beyond those they are specifically designedfor. No known entity has attempted to provide an extended inventoryrange of sterile packaged implants and instruments capable of supportinga large number and wide scope of surgical procedure types. Nor has anyknown entity provided a means for autonomously identifying, locating,and transacting components from the selection available in a mannerwhich not only allows rapid and efficient retrieval of the items, butalso provides inventory management, surgical case management, andelectronic transactions and associated documentation in support of thesurgical procedure. The system and method of the preferred presentinvention addresses the shortcomings of the limited prior art systemsthat lack flexibility for procedures and cannot handle the large numberand wide range of surgical procedure types encountered by typicalhospitals and surgical centers. The system and method of the preferredpresent invention also addresses the limitations of prior art systems bypermitting autonomous identification, location and movement ofcomponents from the selection available to allow rapid and efficientretrieval of items for various surgical procedures.

BRIEF SUMMARY OF THE INVENTION

Briefly stated, in a preferred embodiment, the present invention isdirected to a surgical product supply system for storing, identifyingand tracking surgical equipment and supplies. The supply system includesa first compartment including first, second, third and fourth walls. Thefirst and second walls are comprised of top and bottom walls in thepreferred embodiment and the third and fourth walls are comprised ofside walls in the preferred embodiment. The first compartment may alsoinclude front and rear walls in the preferred embodiment. The first andsecond walls are constructed of a radio-reflective material and thethird and fourth walls are constructed of a radio-absorptive material.The first compartment has a first storage area defined by the first,second, third and fourth walls. A first RFID antenna array is attachedto the first wall and is positioned within the first storage area. Thefirst RFID antenna array includes a first plurality of RFID antennas. Asecond RFID antenna array is attached to the second wall and ispositioned within the first storage area. The second RFID antenna arrayincludes a second plurality of RFID antennas. The first RFID antennaarray includes a first RFID antenna defining a first antenna axis andthe second RFID antenna array includes a second RFID antenna defining asecond antenna axis. The first antenna axis is offset relative to thesecond antenna axis by an offset distance. A first plurality of surgicalitems is positioned in the first storage area. The first plurality ofsurgical items includes a first surgical item positioned within a firstpackage and a second surgical item positioned within a second package.The first surgical item and the first package are associated with afirst RFID tag and the second surgical item and the second package areassociated with a second RFID tag.

In another aspect, a preferred embodiment of the present invention isdirected to a mobile surgical product supply system for storing,identifying and tracking surgical equipment and supplies. The mobilesupply system includes a first compartment including first, second,third and fourth walls. The first and second walls are constructed of aradio-reflective material and the third and fourth walls are constructedof a radio-absorptive material. The first compartment has a firststorage area defined by the first, second, third and fourth walls. Asecond compartment includes fifth, sixth, seventh and eighth walls. Thefifth and sixth walls are constructed of the radio-reflective materialand the seventh and eighth walls are constructed of the radio-absorptivematerial. The second compartment has a second storage area defined bythe fifth, sixth, seventh and eighth walls. A first RFID antenna arrayis attached to the first wall and is positioned within the first storagearea. The first RFID antenna array includes a first plurality of RFIDantennas. A second RFID antenna array is attached to the second wall andis positioned within the first storage area. The second RFID antennaarray includes a second plurality of RFID antennas. A third RFID antennaarray is attached to the fifth wall and is positioned within the secondstorage area. A fourth RFID antenna array is attached to the sixth walland is positioned within the second storage area. A first plurality ofsurgical items is positioned in the first storage area. The firstplurality of surgical items includes a first surgical item positionedwithin a first sterile package and a second surgical item positionedwithin a second sterile package. A first RFID tag is attached to thefirst sterile package and a second RFID tag is attached to the secondsterile package. The first and second RFID antenna arrays are configuredto periodically scan the first plurality of surgical items to determinea first number of surgical items in the first plurality of surgicalitems. A second plurality of surgical items is positioned in the secondstorage area. The second plurality of surgical items includes a thirdsurgical item positioned within a third sterile package and a fourthsurgical item positioned within a fourth sterile package. A third RFIDtag is attached to the third sterile package and a fourth RFID tag isattached to the fourth sterile package. The third and fourth RFIDantenna arrays are configured to periodically scan the second pluralityof surgical items to determine a second number of surgical items in thesecond plurality of surgical items.

The preferred present invention relates to an inventory supply andmanagement system and method for making implants, instruments, and otherdevices for general surgery and, more specifically, orthopedic surgery,available in a manner which provides an efficient and user-friendlysystem and method for rapidly identifying, monitoring, managing, andlocating within the inventory supply system at the location, surgicalproducts used in support of a surgical procedure.

In accordance with the preferred present invention, a mobile inventoryrepository and accounting system (collectively “automated CART”) forproviding surgical implants, instruments, and other medical devices(collectively “items”) for general, and more specifically orthopedic,surgery is sufficiently large such that it may contain more than threehundred (300) individually sterile packaged items in one or moreindividual internal compartments, although non-sterile packaged itemsmay also be contained either primarily or supplementary to the sterilepackaged items. The automated CART is also mobile and capable of beingeasily relocated and sized to be accommodated within a surgicaloperating room, and such automated CARTs may be capable of containing upto two thousand (2000) packaged items or more. In the preferredembodiment, each packaged item within the automated CART has a radiofrequency identification (“RFID”) tag affixed thereto. The CART,accordingly, contains transponders capable of interacting with the RFIDtags, specifically RFID antennae, controlled by an appropriate RFIDreader, and designed for communication with the corresponding item RFIDtags. Because the cart may contain a substantial density of RFID taggeditems that contain metal, commonly used RFID transponder configurationsmay not provide sufficient performance in communicating with the RFIDtagged items.

The application needs of the preferred embodiment of the automated CARTinclude several conflicting requirements with respect to standard RFIDtechnology for implementing the system, thus requiring novelconfigurations of the embodied components described herein. Theautomated CART system requires fast reads of large numbers ofinexpensive tags surrounded by metallic items in a small contained radiofrequency-isolated environment. Because the contents of the taggedpackages are substantially metallic, the optimal choice of RFIDtechnology is a low frequency (“LF”) system, however ultra-highfrequency (“UHF”) systems are optimal for reading higher quantities oftags more quickly. LF systems are not as fast nor are they as effectivein high tag density environments. UHF systems have difficulty reliablyreading tags in a metallic environment due to substantial reflections ofradio frequency (“RF”) energy and detuning of tag antennas, causing ascrambled, rather than backscattered, signals. Passive inlay UHF tagsare inexpensive, however, they are commonly tuned and packaged for useon dielectric (non-metallic) materials. Passive UHF tags have been, andcontinue to be, developed for use on or near conductive (i.e., metallic)materials, however these tags are significantly more expensive and,therefore, prohibitive for single and disposable use.

Passive UHF tags are also susceptible to mutual detuning and reducedread-range due to backscatter energy falloff at acute azimuth andelevation angles relative to the antenna plane. The automated CARTtypically has substantial package (i.e., tag) density and, thus, packageorganization and associated package label presentation is preferablyeffective for users to easily and reliably visually locate the desireditem within the containment system. The substantial density and theassociated arrangement of the packages to optimize meeting the userneeds, can conflict with the optimal performance of the RFID system.Adding to the conflict, in the preferred embodiment, the automated CARTsystem package containment size generally results in a substantialportion of the packages located within close proximity to RFID antennas,but not necessarily within the antenna beam pattern that would providesufficient gain for adequate backscatter, thus diminishing thereliability and accuracy of tag-reads. The tag-read reliability can beimproved by implementing RF-reflective surfaces within the containmentspace, however, backscatter from tags within high-gain regions of thebeam pattern will also reflect, possibly with sufficient energy toundermine detectability of lesser-power tag emissions. Conversely,RF-absorptive material can be utilized within the containmentconfiguration to reduce the backscatter reflective energy of tags withinhigh antenna-gain beam regions, however, that effect negatively impactsthe readability of tags in low-gain beam regions.

In a preferred embodiment, packages are arranged within the automatedCART in organized rows within drawers of a mobile automated CART.Package density and label visibility within each drawer is optimized byorienting the largest surface area of a package substantiallyvertically. The RFID tag is placed at a location on the package surfacethat is sufficiently large and sufficiently distant from the enclosedmetallic item, that being on the near-vertical surface. The packages arealso preferably arranged such that the vertical surfaces containing theRFID tags are sufficiently distant from a neighboring tag on a packagesurface to avoid tag-to-tag detuning. The packages are arranged in thepreferred embodiment in a plurality of drawers within the automatedCART, two of which are proximate to an upper and a lower side of thecontainment structure, respectively. Depending on the configuration ofthe drawers and packages, the package tags contained in those drawersmay be in very close vertical proximity of the upper or lowercontainment structure surfaces and may be very near the extremeboundaries of those surfaces, i.e., front, back, left or right sides,thus located outside of the optimal antenna beam region for tag reads.

To overcome the CART-imposed deficiencies of weak backscatter from tagsoutside high-gain regions of the antenna beam pattern, nearRF-absorptive surfaces, and with non-optimal RFID tag orientations,antennas are preferably mounted on two opposing surfaces of thecontainment box. In the preferred embodiment, antennas are mounted onthe upper and lower surfaces. Additionally, a plurality of relativelylow-gain circular antennas, forming an antenna array, is typicallyutilized for both the top and bottom surfaces. The antenna arrays arepreferably arranged such that no two opposing antennas are directly inline vertically with one another and their locations are optimized toprovide sufficient gain antenna beam coverage of packages located inclose proximity to the opposing antenna array as well as to thecontainment surface borders. Additionally, the antenna arrays in thepreferred embodiment are mounted on RF reflective surfaces to augmentboth RF emissions from the antennae and backscatter from close-proximitytags. Low-gain antennas, e.g., approximately three decibel (3 dB)antennas, are used to counteract the otherwise significant RF energyproduced by the plurality of antennas within the arrays, and therebyminimize the amount of reflected backscatter energy and optimize thereadability of all tags within the containment volume in conjunctionwith other optimized design elements as stated herein.

In the preferred embodiment, a plurality of sub-compartments within theautomated CART containment system segregate inventory items for thepurposes of radio frequency isolation and item location. At least one ofthe sub-compartments within the automated CART retains the same featuresas described above regarding antennas, items, packaging, packageplacement, and structural materials. The RFID sensing system associatedwith one sub-compartment is preferably restricted to read tags onlywithin that sub-compartment. In similar fashion, a neighboringsub-compartment RFID sensing system typically cannot read tags locatedin the first sub-compartment. This configuration provides for a grossmeans of associating specific items to a sub-compartment, therebyfacilitating item searches by limiting regions of the automated CART. Afiner means of item location is provided for by sequential tag-readinterference of individual package tags within a sub-compartment duringa RFID read session. Each item is preferably associated with a specificlocation within a drawer row and column by blocking, e.g., detuning,individual tag reads with the exception of one single tag, thenassociating the sole tag identified to that unblocked location. Thisprocess is sequentially repeated until all item locations have beenread. Alternatively, session types can be used to restrict tags fromreporting back once they have been inventoried, so blocking previouslyinventoried tags is generally not needed. The tag/location data is thenstored for reference and utilized when item searches are initiated.Additionally, the automated CART preferably contains at least one RFIDantenna in isolation from all compartments or sub-compartments. Itemsconsumed, i.e., removed, from the automated CART may be identified byplacing the associated RFID tag in proximity to this isolated antennaand performing a tag read, as well as by subsequent tag reads within thecompartments to compare the item inventory before and after aconsumption period.

In the preferred embodiment, the automated CART typically retains allitem identification data obtained from the associated item RFID tag in acomputational means containing physical memory. The item data stored inthe RFID tag preferably includes a part number, a unique serial number,and package expiration date, however, other pertinent information usefulto the surgical case or transaction of the item may also be included inthe tag memory. The automated CART also has a communication means thatallows wired or wireless communication to a remote server maintaining adatabase that can be synchronized with the data located in the automatedCART computational means physical memory. As items are added or removedfrom the automated CART, the transactions are monitored and logged andinventory updates are sent to the remote server or central server. Insimilar fashion, when items are added to the remote server, e.g., newitems in a main warehouse location or new part numbers, and subsequentlyphysically added to the automated CART, the items will be scanned, addedto the physical memory, and transacted through the communication meansto change the inventory location on the remote server. Additionally,when items are removed from the automated CART, as determined by themethod described in brief above and in detail below, transactions arecommunicated to the remote server and associated billing activities canbe initiated automatically. Information supporting the contained items,including but not limited to item specifications, instructions for use,quantities available, surgical technique guides, and the like,maintained in the automated CART physical memory and synchronized withthe remote server is made available to the user and can be providedautomatically through sensing of the RFID tag associated with the itembefore, during, or after removal and/or consumption of the item forsurgery. Also in the preferred embodiment, information linking both theitem, the facility in which the automated CART is located, the surgicalprocedure, and/or an individual surgeon, may be stored in the automatedCART computational means physical memory to facilitating locatingassociated surgical items within or outside the automated CART, as wellas providing transactional information integral to billing, item usagepatterns, procedure scheduling, inventory replenishment, and the like.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments of the surgical supply system, relatedinstruments, related implants, related items and methods of thepreferred embodiments of the present invention, will be betterunderstood when read in conjunction with the appended drawings. For thepurposes of illustrating the preferred surgical supply system andrelated methods, there are shown in the drawings preferred embodiments.It should be understood, however, that the preferred invention is notlimited to the precise arrangements and instrumentalities shown. In thedrawings:

FIG. 1 is a front perspective view of a surgical product supply systemincluding a CART in accordance with a preferred embodiment of thepresent invention;

FIG. 2 is a magnified front perspective view of packaged items andassociated RFID tags for placement in the surgical product supply systemof FIG. 1;

FIG. 3 is a magnified, partially transparent, front perspective view ofthe surgical product supply system of FIG. 1, with an RFID antenna arrayarrangement on the CART;

FIG. 4 is a partially transparent, front perspective view of acompartment of the surgical product supply system of FIG. 1, showingantenna placement with a beam pattern associated with the compartment;

FIG. 5 is front perspective view of a compartment of the surgicalproduct supply system of FIG. 1, wherein the compartment contains alarge number of packaged items;

FIG. 6 is a block diagram of functional blocks making up an automatedCART in accordance with the surgical product supply system of FIG. 1;

FIG. 7 is a front perspective view of a package slot of the surgicalproduct supply system of FIG. 1, wherein the package slot includes ameans to selectively read single package RFID tags to determine itemlocation;

FIG. 8 is a block flow diagram of a preferred process to determine itemlocation of a packaged item of the surgical product supply system ofFIG. 1;

FIG. 9 is a block diagram of a local and remote databases containingitem location information in accordance with the surgical product supplysystem of FIG. 1;

FIG. 10 is a block diagram of local and remote databases containingitem/surgery relationship information in accordance with the surgicalproduct supply system of FIG. 1; and

FIG. 11 is an alternative front perspective view of the surgical productsupply system of FIG. 1, with different product packages and itemspositioned therein.

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenienceonly and is not limiting. Unless specifically set forth herein, theterms “a”, “an” and “the” are not limited to one element but insteadshould be read as meaning “at least one”. The words “right”, “left”,“lower” and “upper” designate directions in the drawings to whichreference is made. The words “inwardly” or “distally” and “outwardly” or“proximally” refer to directions toward and away from, respectively, thepatient's body, or the geometric center of the preferred surgicalproduct supply system and related parts thereof. The words, “anterior”,“posterior”, “superior,” “inferior”, “lateral” and related words and/orphrases designate preferred positions, directions and/or orientations inthe human body to which reference is made and are not meant to belimiting. The terminology includes the above-listed words, derivativesthereof and words of similar import.

It should also be understood that the terms “about,” “approximately,”“generally,” “substantially” and like terms, used herein when referringto a dimension or characteristic of a component of the preferredinvention, indicate that the described dimension/characteristic is not astrict boundary or parameter and does not exclude minor variationstherefrom that are functionally the same or similar, as would beunderstood by one having ordinary skill in the art. At a minimum, suchreferences that include a numerical parameter would include variationsthat, using mathematical and industrial principles accepted in the art(e.g., rounding, measurement or other systematic errors, manufacturingtolerances, etc.), would not vary the least significant digit.

Referring to FIGS. 1-11, in the preferred embodiment of the presentinvention, a mobile inventory repository and accounting system(collectively “automated CART”) for a surgical product supply system,generally designated 100, is utilized to provide surgical implants,instruments, and other medical devices (collectively “items”) forgeneral, and more specifically, orthopedic surgery. The automated CARTand surgical product supply system 100 preferably includes containmentmeans, sensing means, computational means, and communication means forcollecting, storing, transmitting, retrieving, presenting, andprocessing information about the items placed therein and maintaininglocal and synchronized remote data regarding item retrieval and usage ina surgical procedure. Effective application of the preferred system 100includes the automated CART to support containment of a substantiallyhigh density of items, many of which are typically constructed ofmetallic materials, packaged with low cost RFID tags affixed to each.Additionally, the system 100 preferably, automatically, rapidly, andaccurately monitors the contained items, accounts for any transactions,and reports transactional activities to a remote server/database of thesystem 100.

Referring to FIG. 1, in the preferred embodiment, the surgical productsupply system 100 provides a specific environment to house the inventoryof items for a relatively large number of surgical procedures andsupports the functions of the automated CART. This environmentpreferably facilitates a large number of inventory items in a space oron the CART that has a substantial density of packaged items. The system100 preferably provides storage in a manner allowing for uncompromisedfunctioning of the sensing means. As shown in FIG. 1, the containmentmeans of the surgical product supply system 100 includes one or morecompartments 110, 120, 130, 140, each incorporating a plurality of RFIDantennas 150. The compartments preferably include a first compartment110, a second compartment 120, a third compartment 130 and a fourthcompartment 140. Each compartment 110, 120, 130, 140 is configured tocontain in an organized manner a plurality of packaged surgical items,which are described in greater detail below, of substantially metalliccomposition (not shown), each incorporating an RFID tag to operate incooperation with the associated RFID antennas 150. The containment meansof the surgical product supply system 100 also physically houseselectronic components (not shown) making up the sensing, computational,communication, and power management mechanisms for the automated CARTsystem. The power management system includes a system for receivingpower from standard alternating current (“AC”) wall outlets andconverting AC power to direct current (“DC”) power, as well asmaintaining charging of on-board power backup batteries, which allow theautomated CART to be easily moved (i.e., mobile) with no or limited lossof function during or after relocation and also remain functional whennot plugged in or during a limited power outage. The containment meansof the surgical product supply system 100 also includes a plurality ofwheels 115 allowing the automated CART to be mobile and easilyrelocated.

In the preferred embodiment, the first compartment 110 includes a firstwall 110 a, a second wall 110 b, a third wall 110 c and a fourth wall110 d. The first and second walls 110 a, 110 b are constructed of aradio-reflective material and the third and fourth walls 110 c, 110 dare constructed of a radio-absorptive material. In the preferredembodiment, the radio-reflective material of the first and second walls110 a, 110 b is comprised of a metallic material and theradio-absorptive material of the third and fourth walls 110 c, 110 d iscomprised of carbon-fiber sheet material. The radio-reflective materialis not limited to being comprised of metallic materials and may becomprised of nearly any material that is able to take on the generalsize and shape of the first and second walls 110 a, 110 b, withstand thenormal operating conditions of the first and second walls 110 a, 110 b,and perform the functions of the first and second walls 110 a, 110 b, asis described herein. The radio-absorptive material is similarly notlimited to being comprised of carbon-fiber sheet material and may becomprised of nearly any material that is able to take on the generalsize and shape of the third and fourth walls 110 c, 110 d, withstand thenormal operating conditions of the third and fourth walls 110 c, 110 d,and perform the functions of the third and fourth walls 110 c, 110 d, asis described herein.

The preferred first compartment 110 has a substantially boxy orcubic-like shape with the first and second walls 110 a, 110 b comprisingthe top and bottom walls, the third and fourth walls 110 c, 110 dcomprising the side walls and a first rear wall 110 e comprising therear wall of the first compartment 110. The preferred first compartment110 may also include a front wall that may be constructed of eitherradio-reflective or radio-absorptive material or a combination of both.The front wall and rear walls are preferably constructed ofradio-absorptive material. The first compartment 110 and the additionalcompartments 120, 130, 140 preferably have boxy or cubic-like shapes andare sized substantially the same relative to each other, but are not solimited. The compartments 110, 120, 130, 140 may have nearly any sizeand shape that is able to receive and store surgical equipment andsupplies therein, withstand the normal operating conditions of thecompartments 110, 120, 130, 140 and perform the preferred functions ofthe compartments 110, 120, 130, 140. In the preferred embodiment, thefirst wall 110 a and the second wall 110 b are spaced apart at a firstantenna array distance D₁ that is less than thirty-six inches (36″). Thesecond compartment 120, the third compartment 130 and the fourthcompartment 140 also preferably have top and bottom walls that arespaced apart at second, third and fourth antenna array distances D₂, D₃,D₄, respectively, that are substantially the same as the first antennaarray distance D₁, but are not so limited, and may have differentdimensions and sizes depending on designer or user preferences andlimitations. The first, second, third and fourth walls 110 a, 110 b, 110c, 110 d are not limited to being relatively planar and rectangular andmay have a curved or arcuate shape, as long as the first compartment 110defines the first storage area 111, which is able to receive and storethe plurality of surgical items 210, 510 therein.

The first compartment 110, as well as the second, third and fourthcompartments 120, 130, 140 of the preferred embodiment are connected toa mobile cart or include the wheels 115 such that the compartments 110,120, 130, 140 are mobile for transport, particularly for transportaround a medical facility. The compartments 110, 120, 130, 140 are notlimited to being connected to a cart, having the wheels 114 or otherwisebeing movable, but are preferably mobile for movement of the surgicalequipment and supplies about the medical facility, surgical center,hospital or generally other areas so that the surgical equipment andsupplies can be utilized in different areas.

The first compartment 110 preferably has a first storage area 111defined by the first, second, third and fourth walls 110 a, 110 b, 110c, 110 d. The second, third and fourth compartments 120, 130, 140 alsopreferably have second, third and fourth storage areas 121, 131, 141defined by their respective top, bottom and side walls. The surgicalequipment and supplies are preferably positionable within the first,second, third and fourth storage areas 111, 121, 131, 141 during use.

The second compartment 120 preferably has a second storage area 121defined by fifth, sixth, seventh and eighth walls 120 a, 120 b, 120 c,120 d. The fifth and sixth walls 120 a, 120 b are preferably constructedof the radio-reflective material and the seventh and eighth walls 120 c,120 d are preferably constructed of the radio-absorptive material. Thefifth and sixth walls 1201 a, 120 b are preferably comprised of the topand bottom walls of the second compartment 120 and the seventh andeighth walls 1201 c, 120 d are preferably comprised of the side walls ofthe second compartment 120, but are not so limited and may be otherwisearranged and shaped, based on user preferences and requirements. Thethird and fourth compartments 130, 140 also similarly include top,bottom and side walls that define third and fourth storage areas 131,141 for receipt of the surgical equipment and supplies. The firststorage area 111 and the second storage area 121 preferably define afirst volume and a second volume. The first volume is preferably lessthan seven cubic feet (7 ft³), but is not so limited and may be smalleror larger depending on the arrangement of the first compartment 110, thesurgical equipment and supplies stored in the first storage area 111 andadditional factors. For example, the first volume may be approximatelyone to fourteen cubic feet (1-14 ft³) for storing pluralities ofsurgical items 210 and packages 230. The second, third and fourthstorage areas 121, 131, 141 preferably have the same or similar volumeas the first volume and is similarly no so limited.

The preferred surgical supply system 10 includes the plurality of RFIDantennas 150 attached to the first, second, third and fourthcompartments 110, 120, 130, 140, preferably within the first, second,third and fourth storage areas 111, 121, 131, 141. The plurality of RFIDantennas 150 are mounted to the radio reflective walls of thecompartments 110, 120, 130, 140, including the first, second, fifth andsixth walls 110 a, 110 b, 120 a, 120 b and the upper and lower walls ofthe third and fourth compartments 130, 140. The plurality of RFIDantennas 150 include a first antenna array 151 attached to the firstwall 110 a and the first antenna array 151 is positioned within thefirst storage area 111. The first antenna array 151 includes a firstplurality of or at least two (2) RFID antennas 151 a, 151 b, 151 c, 151d with the preferred first plurality of RFID antennas 151 a, 151 b, 151c, 151 d comprised of four (4) RFID antennas 151 a, 151 b, 151 c, 151 dmounted to an underside of the first wall 110 a. The plurality of RFIDantennas 150 also includes a second RFID antenna array 152 attached tothe second wall 110 b and the second antenna array 152 is positionedwith in the first storage area 111. The second RFID antenna array 152includes a second plurality of or at least two (2) RFID antennas 152 a,152 b, 152 c, 152 d with the preferred second plurality of RFID antennas152 a, 152 b, 152 c. 152 d comprised of four (4) RFID antennas 152 a,152 b, 152 c, 152 d mounted to a top side of the second wall 110 b. Thefirst and second antenna arrays 151, 152 are not limited to includingthe four RFID antennas 151 a, 151 b, 151 c, 151 d, 152 a, 152 b, 152 c,152 d and may include nearly any number of RFID antennas that are ableto detect the surgical equipment and supplies within the first andsecond compartments 110, 120, respectively. In addition, the pluralityof RFID antennas 150 are not limited to utilizing RFID technology andmay be otherwise comprised sensors, such as visual or other sensors thatare able to detect the presence or absence of particular surgicalequipment and supplies within the storage areas 111, 121, 131, 141during operation.

The first RFID antenna array 151 includes a first RFID antenna 151 adefining a first antenna axis A1 and the second RFID antenna array 152includes a second RFID antenna 152 a defining a second antenna axis A2.The first antenna axis A1 is offset relative to the second antenna axisA2 by an offset distance Do. The first and second antenna axes A1, A2preferably extend substantially parallel relative to each other, extendgenerally through a center of the first and second RFID antennas 151 a,152 a, respectively and extend generally parallel to a vertical axis Xof the preferred surgical product supply system 10. The vertical axis X,as well as the first and second axes A1, A2 preferably extend generallyvertically, but are not so limited and preferably extend substantiallyparallel to a sensing direction of the RFID antennas 151 a, 151 b, 151c, 151 d, 152 a, 152 b, 152 c, 152 d of the first and second antennaarrays 151, 152. The first and second RFID antennas 151 a, 152 a arepreferably spaced at the offset distance Do such that the first andsecond RFID antennas 151 a, 152 a detect different volumes within thefirst storage area 111 to detect different ones of the surgicalequipment and supplies within the first storage area 111. Each of thefirst, second, third, fourth, fifth, sixth, seventh and eighth antennaarrays 151, 152, 153, 154, 155, 156, 157, 158 include four (4) RFIDantennas, but are not so limited and preferably include at least two (2)RFID antennas, but may include more RFID antennas to cover a greatervolume in the storage areas 111, 121, 131, 141. The preferred thirdantenna array 153 is attached to the fifth wall 120 a and the fourthRFID antenna array 154 is attached to the sixth wall 120 b of the secondcompartment 120, such that the third and fourth RFID antenna arrays 153,154 are positioned within the second storage area 121. The fifth andsixth RFID antenna arrays 155, 156 are preferably positioned within thethird storage area 131 and the seventh and eighth RFID antenna arrays157, 158 are preferably positioned within the fourth storage area 141.

Referring to FIGS. 1, 2 and 9, for the purpose of accommodating a largenumber of packaged items with substantial density, a preferred examplecontainment means 200 of the preferred embodiment allows each of theplurality of contained packaged surgical items, e.g., a bone screw 210,having one RFID tag 220 affixed to the package 230, to be arranged andheld within at least one of the first, second, third and fourthcompartments 110, 120, 130, 140 in an organized manner with separationdistances orthogonal to first and second package planes 240, 250 ofindividual first and second packages 230 a, 230 b. The first and secondpackage planes 240, 250 of the first and second packages 230 a, 230 b ofthe preferred embodiment are separated by a separation distance D₅ thatis preferably no greater than two and one-half inches (2.5″), but arenot so limited and may be spaced at a slightly greater distancedepending on the size and shape of the item 210 or at a smallerdistance. In the preferred embodiment, a substantial portion, i.e.,greater than eighty percent (80%) of the contained, packaged, surgicalitems 210 within at least one of the compartments 110, 120, 130, 140 areorganized within the respective storage areas 111, 121, 131, 141 suchthat the separation distances D₅ orthogonal to RFID tag surface planes,such as the first and second package planes 240, 250, are no greaterthan two and one-half inches (2½″) and more preferably no greater thanone inch (1″). Furthermore, the separation distance D_(S) between any ofthe RFID tags 220 and at least one item 210 within the associatedpackage 230 is no greater than one inch (1″). At least one compartment110, 120, 130, 140 is preferably capable of containing at least threehundred (300) packaged items 210. A substantial percentage of thepackaged items 210 are constructed of metallic items, which are typicalfor surgical items 210, but are not so limited, as the items 210 may beconstructed of polymeric, allograft or other biocompatible materials.The containment means of the preferred surgical product supply system100 may include a total internal volume no greater than twenty cubicfeet (20 ft³) and at least one compartment 110, 120, 130, 140 may have atotal internal volume of no greater than seven cubic feet (7 ft³), butare not so limited and may have alternative sizes and shapes, based onuser or designer requirements or preferences.

In the preferred embodiment, the containment means of the automated CARTor surgical supply system 10 includes one or more substantially radiofrequency-isolated compartments, such as the first, second, third andfourth compartments 110, 120, 130, 140, for the purpose of substantiallyisolating the RFID tag-read process within each of the compartments 110,120, 130, 140, as well as the containment means as a whole. Each wall110 a, 110 b, 110 c, 110 d, 110 e, 120 a, 120 b, 120 c, 120 d of thecompartments 110, 120, 130, 140 preferably contains either radiofrequency reflective or absorptive material, thereby effectivelycontaining within the storage areas 111, 121, 131, 141 radio frequencyenergy produced therein. In similar fashion, the compartment walls 110a, 110 b, 110 c, 110 d, 110 e, 120 a, 120 b, 120 c, 120 d mayeffectively exclude from within the storage areas 111, 121, 131, 141nearly all radio frequency energy produced externally. Additionally, atleast one of the compartments 110, 120, 130, 140 preferably has at leastone containment drawer 170. The at least one containment drawer 170preferably has an outward face 172 containing radiofrequency-absorptive, a radio frequency-reflective material or acombination of radio frequency-absorptive and radio frequency-reflectivematerial. The preferred drawer 170 is closable into the storage areas111, 121, 131, 141 and lockable in a closed position within the storageareas 111, 121, 131, 141. The preferred compartments 110, 120, 130, 140may include one or more drawers 170 having various sizes and shapes forcontaining the various packages 230 and surgical items 210 within thestorage areas 111, 121, 131, 141, for example, the preferred drawers 170shown in FIG. 11. The at least one containment drawer 170 may becomprised of a first containment drawer 170 selectively positionablewithin the first storage area 111 and positioned completely within thefirst storage area 111 in a closed position. The first containmentdrawer 170 may include first and second surgical items 210 that may bepackaged or sterile packages or may be positioned within the drawer 170without packaging. The preferably movable containment drawers 170 may beslidable into and out of the first storage area 111 to providerelatively easy access to the packages 230 and the surgical items 210for the users.

In the preferred embodiment, a first plurality of surgical items 201 ispositioned within the first storage area 111. The first plurality ofsurgical items 201 may include the bone screws 210, the RFID tags 220and the packages 230, including the first and second packages 230 a, 230b with the first and second package planes 240, 250, respectively.Reference character 201 is utilized herein to refer to a plurality ofsurgical items 201. A second plurality of surgical items 201, includingpluralities of individual surgical items 210, such as the bone screws210, the RFID tags 220 and the packages 230, are preferably positionedwithin the second storage area 121 for storage and use. The first andsecond pluralities of surgical items 201 are identified generically withreference character 201, but preferably include different combinationsof surgical items 210 and packages 230 that each include a unique RFIDtag 220 to identify the specific surgical items 210 and packages 230, aswill be apparent to one having ordinary skill in the art based on areview of the present application. The surgical items 210 are similarlyidentified generically by reference character 210, but preferablyinclude different surgical items 210 and may include differentquantities of surgical items 210, such as multiple bone screws 210,positioned in one of the packages 230, which are similarly genericallyidentified by reference character 230 such that any of the packages 230,whether sterile or non-sterile, may be generically identified byreference character 230. In addition, each of the packages 230 mayinclude multiple surgical items 210 therein, such as a kit of screws210, a bone plate 210, a surgical instrument 210 and related surgicalitems 210 that comprise a kit of items 210 for performing a particularmedical procedure. The third and fourth compartments 130, 140 alsopreferably include pluralities of surgical items 210 positioned thereinin a working configuration. The second plurality of surgical itemsincludes a third surgical item, such as a bone screw, instrument, boneplate or other surgical item 210, positioned within a third package 230and a fourth surgical item 210 is positioned within a fourth package230. The third and fourth packages 230 are preferably sterile packagescontaining sterile surgical items 210 for implantation or use during therespective procedure related to the surgical item 210.

The first plurality of surgical items 201 preferably includes a firstsurgical item, such as the bone screw 210, positioned within the firstpackage 230 a and a second surgical item, such as a second bone screw210, positioned with in the second package 230 b. The first and secondpackages 230 a, 230 b may be sterile packages or may be non-sterilepackaged, depending on the procedure, the surgical items and otherfactors of the manufacturer or facility where the preferred surgicalproduct supply system 100 is utilized. The first surgical item and thefirst package 230 a are associated with a first RFID tag 220 a and thesecond surgical item and the second package 230 b are associated with asecond RFID tag 220 b. In the preferred embodiment, the first RFID tag220 a is attached to the first package 230 a and the second RFID tag 220b is attached to the second package 230 b. The first and second RFIDtags 220 a, 220 b are preferably attached to the first and secondpackages 230 a, 230 b, respectively, so that the removal of the packages230 a, 230 b may be readily tracked by the surgical product supplysystem 100 and such that the surgical items and instruments 210 may bepackaged without direct contact with the RFID tags 220, 220 a, 220 b.

The first wall 110 a and the second wall 110 b of the first compartment110 preferably define a first wall plane 112 and a second wall plane114, respectively. The first and second walls 110 a, 110 b and the firstand second wall planes 112, 114 are positioned substantially horizontalor perpendicular to the vertical axis X in the preferred embodiment. Thefirst and second package planes 230 a, 230 b are, accordingly,substantially perpendicular relative to the first and second wall planes112, 114. This configuration results in the first and second packageplanes 230 a, 230 b being separated by the separation distance DS, whichis preferably less than two and one-half inches (2½″), but is not solimited and may be smaller or larger depending on sizing of the packages230 and surgical items or instruments 210 and other related factors.

In the preferred embodiment, the first and second RFID antenna arrays151, 152 are configured to periodically scan the first plurality ofsurgical items 201 to determine a first number of surgical items 210that are in the first plurality of surgical items 201. The first andsecond RFID antenna arrays 151, 152 preferably periodically scan thefirst storage area 111 to track the first number of surgical items 210to determine if any of the items 210 are missing, have been used oradditional items 210 have been added since a previous scan. The periodicscanning assists the preferred surgical product supply system 100 inmaintaining inventory control of the first plurality of surgical items210 for several reasons, such as for replenishment of items 210 that areused or for planning purposes to track the frequency of item 210 use.

The preferred surgical product system 100 also preferably includes asecond plurality of surgical items 201 positioned in the second storagearea 121, wherein the second plurality of surgical items 201 includes athird surgical item 210 positioned within a third sterile package 230and a fourth surgical item 210 positioned within a fourth sterilepackage 230. A third RFID tag 220 is attached to the third sterilepackage 230 and a fourth RFID tag 220 attached to the fourth sterilepackage 230. Reference character 220 is utilized herein to genericallyidentify the RFID tags 220, which are preferably attached to thepackages 230 or to the surgical items 210. The third and fourth RFIDantenna arrays 153, 154 are configured to periodically scan the secondplurality of surgical items 210 in the second storage area 121 todetermine a second number of surgical items 210 in the second pluralityof surgical items 210. Similarly, the fifth and sixth antenna arrays155, 156 periodically scan the third storage area 131 and the seventhand eighth antenna arrays 157, 158 periodically scan the fourth storagearea 141 to determine the number of surgical items 210 in the third andfourth storage areas 131, 141.

The preferred surgical product system 100 is constructed with the firstand second compartments 110, 120 stacked onto the third and fourthcompartments 130, 140 in a generally boxy configuration with the wheels115 to permit transport of the system 100. The first and fifth walls 110a, 120 a are both preferably positioned on the first wall plane 112 andthe second and sixth walls 110 b, 120 b are both preferably positionedon the second wall plane 114. The first and second plurality of surgicalitems 201 within the first and second storage areas 111, 121 arepreferably positioned such that their package planes, such as the firstand second package planes 230 a, 230 b are oriented generallyperpendicular to the first and second wall planes 112, 114,respectively. In the preferred embodiment, the first, second, third,fourth, fifth, sixth, seventh and eighth antenna arrays 151, 152, 153,154, 155, 156, 157, 158 include four RFID antennas, but are not solimited and may include less or more RFID antennas.

Referring to FIG. 3, alternative compartments 310, 320, 330, 340 areshown with the walls being partially transparent for clarity. Eachcompartment 310, 320, 330 within the containment means 300 preferablyincludes at least two walls 340 d, 340 e constructed of radio-reflectivematerial of the six (6) walls 340 a, 340 b, 340 c, 340 d, 340 e. Theradio-reflective walls 340 d, 340 e are preferably constructed of ametallic material. In addition, at least two (2) of six (6) walls 340 b,340 c have radio-absorptive material. The radio-absorptive walls 340 b,340 c are preferably constructed of a radio-absorptive material, such ascarbon-fiber. In the preferred embodiment, the top and bottom walls 340d, 340 e are constructed of radio-reflective material and the sidewalls340 b, 340 c are constructed of radio-absorptive material, but are notso limited. In the preferred embodiment, and top and bottom walls 340 d,340 e have a plurality of RFID antennas 350 mounted to theradio-reflective walls 340 d, 340 e between the sidewalls 340 b, 340 c.

Also in the preferred embodiment, the sensing means includes a pluralityof smaller ultra-high frequency (“UHF”) RFID antennas 350 dedicated todetecting and identify items stored within the containment means 300. Tomeet the performance requirements of the automated CART, currentlycommercially available compact UHF antennas, with operating frequenciesranging from eight hundred sixty-five to eight hundred sixty-eightmegahertz (865-868 MHz), typically in Europe, and nine hundred two tonine hundred twenty-eight megahertz (902-928 MHz), typically in theUnited States, with a gain of three decibels (3 dB) are preferred,however utilization of larger gain antennas is contemplated. The sensingmeans for the entire containment system 100 preferably performs RFIDtag-reads of one hundred percent (100%) or nearly one hundred percent(100%) accuracy within a timeframe of less than ten seconds (10 sec)with at least one compartment 110, 120, 130, 140 having a minimumRFID-tagged package density of one hundred fifteen (115) RFID tags 220per cubic foot, and no compartment 110, 120, 130, 140 having less thanan eighty-five (85) tags 220 per cubic foot RFID-tagged package density.The first compartment 110 is preferably able to store approximately sixhundred (600) RFID tagged surgical items 210 when the first compartment110 has a preferred seven cubic foot (7 ft³) volume. In addition, if thefirst compartment 110 has a volume of one cubic foot (1 ft³), the firstcompartment preferably has the capacity of contain at least eighty-five(85) tags 220 or packages surgical items 210 and if the firstcompartment 110 has a volume of fourteen cubic feet (14 ft³), the firstcompartment preferably has the capacity to container at leastapproximately twelve hundred (1200) tags 220 or packages of surgicalitems 210. In the preferred embodiment, a substantial percentage of thepackages 230 within the automated CART containing metallic items. Thehigh package density preferably results in placement of certainRFID-tagged packages 230 to be located in areas substantially close tothe borders of the compartment volume. Such areas limit optimal readingof such RFID tags 220 due to antenna beam pattern restrictions,typically resulting in poor backscatter of RFID tag energy.

Still referring to FIG. 3, optimized coverage of antenna beam patternthroughout the volume of the compartments 110, 120, 130, 140, 310, 320,330, 340 includes a plurality of RFID antennas 350 within at least oneof the compartments 110, 120, 130, 140, 310, 320, 330, 340. The antennas350 are preferably configured on opposed walls 340 d, 340 e in an offsetarray pattern such that no two opposing antennae central axes, forexample, the central axes 360, 370 of opposing antennae 350 shown inFIG. 3, are collinear. The central axes 360, 340 are preferably centeredon the respective antenna 350 and extend generally perpendicular to theantenna ground plane 380 of the respective antenna 350. The opposingRFID antenna arrays 350 are preferably separated at a distance nogreater than thirty-six inches (36″), such as between the top and bottomwalls 340 d, 340 e, but are not so limited. The respective opposingwalls 340 a, 340 b, 340 c, 340 d, 340 e may be alternatively spaced,such as the top and bottom walls 340 d, 340 e being spaced at aseparation distance no greater than eighteen inches (18″), therebyseparating the opposing antenna 350 at approximately eighteen inches(18″).

Additionally, as shown in FIG. 4, at least one compartment 400, which issimilarly constructed and arranged in comparison to the above-describedcompartments 110, 120, 130, 140, 310, 320, 330, 340, includes at leastone antenna 410 within an antenna array 420 placed in coordination withat least one antenna 430 of an opposed antenna array 440, such that anantenna beam 450 coverage with sufficient gain includes a portion of aborder of the compartment volume whereby a packaged item 460, locatedproximate to the compartment border, is otherwise substantially outsideof the direct beam area of sufficient gain of any other antenna of theantenna arrays 420, 440.

Referring now to FIG. 5, in at least one compartment 500, which issimilarly constructed and arranged in comparison to the above-describedcompartments 110, 120, 130, 140, 310, 320, 330, 340, 400, at least fortypercent (40%) of the locations for RFID tagged packages 510 are withinfour inches (4″) of horizontal planes 520, 530 respectively containingopposing arrays of RFID antennas 540, 550 and at least eighty percent(80%) of the contained packaged items 510 are oriented with a surface ofthe RFID tag 521 substantially parallel to a substantially verticalplane 560 oriented substantially orthogonal to the horizontal planes520, 530. In the preferred embodiment, at least one compartment of thecontainment means preferably has a ratio of combined antenna-mountingsurface area on the one of six sides to the combined surface area(ground plane area) of the at least one RFID antenna mounted to the sideno greater than four (4) and at least one compartment has a ratio of thetotal combined six (6) side surface area to the total combined surfacearea (ground plane area) of the RFID antennas no greater than twelve(12).

Referring again to FIG. 1, the containment means of the surgical productsupply system 100 also has at least one extra-compartment isolatedconsumption antenna 160 not within any compartment 110, 120, 130, 140and located in radio frequency-isolation to the compartments 110, 120,130, 140. The preferred embodiment sensing means preferably has a singleRFID reader for controlling all RFID antennas and on-board electroniccomponents including RFID antennas, RFID multiplexers, an RFID reader,and a General-Purpose Input/output switch (GPIO) (not shown). It iscontemplated that alternative preferred embodiments may include morethan one RFID reader controlling antenna arrays either in separatecompartments or shared within compartments 110, 120, 130, 140, 310, 320,330, 340, 400.

Also in the preferred embodiment and as shown in FIG. 6, the surgicalproduct supply system 100 includes communication means. Thecommunication means preferably comprises on-board electronic componentsincluding an Ethernet modem, a Wi-Fi modem, a cellular data modem, or acombination thereof. The communication means of the preferred surgicalproduct supply system 100 is capable of transferring data between thesensing means and the computational means, as well as between thecomputational means and a remote server 180 via the internet, but is notso limited and may communicate in other mediums.

Also in the preferred embodiment and as is shown in FIG. 6, thecomputational means includes a computer system and associatedmicroprocessor, data storage, input/output ports, and user interface(i.e., monitor, barcode scanner, mouse, and the like). The monitor or acombination of computer and monitor all-in-one, preferably includes atouch screen for user interaction, a speaker system for providing audio,and a microphone for receiving voice commands. The computational meansincorporates software to manage and control the sensing means, allowsthe user interaction with the automated CART and controls communicationthrough a modem to and from the sensing means and to and from theinternet to a remote database. The software also acts through thecommunication means to receive and interpret data from the sensor meansand manage storage of the received item data utilizing an electronicdata storage means, preferably a database, to retain item data read frompackage RFID tags 220, as well as item information input through a userinterface within the computational means, including itemcharacteristics, surgical case data, repository inventory, itemtransactions, and use relationships. The software also includes thecapability to identify, collect, and store RFID tag content informationon one or more RFID tags 220 removed from the containment system,associate and store RFID tag content information with productinformation contained in a local database, synchronize a local databaseof product information with a remote database, synchronize a localdatabase of surgical-related information with a remote database, andsynchronize a local database of consumed product transactions with aremote database.

In the preferred embodiment, the software also includes logic algorithmsto analyze electronic location information provided by the containmentmeans to provide user-understandable location information (e.g., via agraphical user interface, LED light identifiers, and the like). Theautomated CART is preferably configured with a plurality of drawers,each containing a plurality of slotted inserts designed to organize andhold a sterile packaged item 210, 510 within each of the slots (See FIG.11). The sensing means within the cart enables identification of thecontents of each item 210, 510 and the specific slot location. Locationidentities may be determined in a variety of known ways, includingproviding for a single antenna for each slot and isolating eachantenna/slot combination such that only the RFID tag associated with thepackage 230 in the corresponding slot is read. However, alternativenovel means for correlating an item and its slot location is describedherein. As previously described, the sensing means includes a pluralityof RFID sensing antennas located strategically within at least onecompartment, sufficient in number and position to effectively read allthe item tags located within the compartment volume.

As shown in FIG. 7, each package slot 700 has a small blocking antenna710 designed such that upon energization, the blocking antenna signalsubstantially detunes a single select item RFID tag 720 associated withthat package slot 700 such that it cannot produce backscattersufficiently and, therefore, not be detected by the sensing meansantennas (not shown). Alternatively, using mechanical means rather thanelectronic means, a metallic blocking element (not shown) of sufficientarea may be moved from a location sufficiently distant from a singleselect item RFID tag 220, 720 to a location sufficiently proximate tothe select item RFID tag, to effectively not interfere with oreffectively detune the select item RFID tag 220, 720, respectively. Whenin sufficient proximity to the select item RFID tag 220, 720, themetallic blocking element sufficiently detunes only the select item RFIDtag 220, 710 thereby causing the select item RFID tag 220, 720 to emitscrambled and unrecognizable energy rather than backscatter energy thesingle select RFID tag 220, 720 would emit if not detuned. Bystrategically implementing the blocking antennas or metallic blockingelements at all package slot 700 locations within a specified volume,e.g., compartment, except a single slot 730, the single RFID tag 220,720 is capable of being read during this time period is correlated tothe slot 700 that does not have the blocking antenna energized, ormetallic element repositioned, and subsequently this relationshipbetween the item identity and package slot 700 location is logged to thememory of the computational means. This process is sequentiallyperformed at all slot pairs within the specified volume therebycollecting identification data corresponding location information forall items, as shown in FIG. 8. Subsequently, this information isprovided to the user via the user interface by which the user isdirected to the specific slot location for retrieval of the desireditem, as shown in FIG. 9.

The preferred embodiment of the containment means provides for aplurality of radio frequency isolated compartments 110, 120, 130, 140effectively serving as gross means for an alternative embodiment toassigning locations to packaged item identification information withinthe automated CART. In such a configuration, packaged items areidentified using the associated RFID tag information and their locationis associated to the compartment 110, 120, 130, 140, 310, 320, 330, 340from within which the tag was sensed. An additional embodiment providingfor a finer location resolution utilizes a limited version of thepackage slot blocking embodiment that segregates location information toregions within a compartment 110, 120, 130, 140, 310, 320, 330, 340.Larger blocking antennas 740 and/or metallic blocking elements (notshown) are implemented in regions of package slots within specificdrawers or areas of a compartment 110, 120, 130, 140, 310, 320, 330,340. In a similar manner as above, all but one region would have theirblocking antennas energized, or blocking metallic elements repositioned,at any one time, thereby allowing the system 100 to read the itemslocated in the unblocked region. This then allows a limited number ofitems to be identified as having a location in the known region. Whilethe system 100 would not be able to locate an item to a specific slotlocation as in the preferred embodiment, implementation would be lesscostly and it would still provide greater efficiency to the usercompared to a location correlated to the whole of a compartment orautomated CART.

In the preferred embodiment, the method of adding, identifying,removing, transacting, and reporting inventory items is performed by thecombination of the containment means, the sensing means, thecomputational means, and the communication means. When a new item isadded to the automated CART, the item is placed within a compartment110, 120, 130, 140, 310, 320, 330, 340 in an organized fashiondetermined by the containment means and as described above for thepreferred embodiment. The sensing means polls the inventory itemsutilizing the RFID tags 220, 720 and reports the identities of thecontained items 210, 510, along with relevant item information stored inthe tags 220, 720, to the computational means. The computational meansrecognizes the newly added items 210, 510, storing the information andalso reporting the information to a remote server 180 via thecommunication means. Item part numbers are preferably verified againstthe local database within the computational means physical memory and,in the preferred embodiment, associated serial numbers for each item210, 510 are recorded. This information is synchronized with a remoteserver database and item serial numbers are utilized to transact thecorresponding inventory items from a previous location, e.g., a mainwarehouse, to the automated CART containment means location. Thecomputational means also receives information from the remote server forany new item part number that does not have a data record in the localmemory of the computational means. Such information includes specificphysical and descriptive characteristics that are used to provideadditional information about the item to the automated CART user forsearching, reference, or instruction. This process also providesvalidation of part numbers and serial numbers of new items introducedinto the automated CART, whereby the user is can be alerted to any itemor items 210, 510 that do not have a corresponding identity, i.e., partnumber, serial number, or both, in the remote database, indicating adata error.

In the preferred embodiment, and in addition to serial numbers, packageexpiration dates are preferably included in RFID item tag data andassociated within the local database to the item serial number.Alternatively, package expiration dates may be maintained in the remotedatabase, communicated to the automated CART local database, and addedto the item data record locally. Lead times ahead of the expiration dateare provided by the remote database, or entered locally via thecomputational means user interface, for the purpose of initiating analert indicating the impending timeline for the specific item 210, 510.The expiration alert, including the item part number, serial number, andexpiration date, is communicated to the remote server and also indicatedon the user interface of the communication means. The automated CARTsoftware is programmed to disallow consumption of an expired item 210,510, when either within an expiration lead time or past the expirationdate according to the instructions provided to the software. Proceduresfor removing expired or near-expired items 210, 510 are initiated uponacknowledgement of the computational means package expiration alert.

Additionally, upon removal of an inventory item 210, 510, the sensingmeans determines the identity or identities of the item or items 210,510 no longer within the preferred compartments 110, 120, 130, 140. Inthe preferred embodiment, again referring to FIG. 1, theextra-compartment isolated consumption antenna 160 is utilized asdescribed elsewhere herein. The removed item data, i.e., serial numberthat is associated with one of the RFID tags 220, is identified ashaving been consumed in the computational means or local server and theinformation is recorded locally and reported to the remote server viathe communication means, such as the extra-compartment isolatedconsumption antenna 160. Additionally, the computational means providesa user interface that allows a consumer of the automated CART inventoryitems to log the items removed and consumed, i.e., used for surgery,from the containment means. The computational means then associates theitem information, e.g., part number and serial number, with specificinformation regarding the surgical facility and other informationregarding the surgical case, e.g., surgeon, body site, surgicalapplication, etc., to create a consumption report, account for theconsumption in a surgical case data record, and transfer the consumptiondata record to a remote server via the communication means. The specificitem 210, 510, preferably identified by serial number, is thendecremented from the automated CART inventory at both the local databaseand the remote database. Additionally, consumption transactions areelectronically or manually generated and provided to the consumingentity for accounting and billing activities. These and other activitiesdescribed further below are shown in FIG. 10.

An alternative consumption process is implemented within the preferredembodiment whereby the extra-compartment isolated consumption antenna160 is not utilized by the consumer. The RFID tags 220, 720 associatedwith the packaged inventory contained within the automated CART areperiodically scanned by the sensing means as previously described,thereby providing an updated accounting for all serial numbers heldwithin the containment means. This item list is compared with apreviously scanned contained item inventory list by the computationalmeans, accounting for any intentionally consumed and scanned items, todetermine unaccounted for items and provide an alert to both the localuser and the remote database.

Consumption data for each item 210, 510 is accumulated into the localdatabase within the computational means, whereby specific iteminformation can be retrieved, assimilated, grouped, and filtered asrequired. Input from the user, through the user interface, includinginformation regarding the relationships between the inventory items 210,510 and surgical use, is included within the data accumulated in thelocal database. For example, such a relationship within an orthopedicsurgical case, at a specific surgical facility, and for a specificsurgeon, could define that a specific drill bit and/or screw driver 210,510 is used with a specific screw and a specific drill guide is usedwith the recommended drill bit. This information would be capturedperiodically and accumulated over time and provided to a user through auser interface, i.e., monitor.

As an example of the utility of the system 100 in an orthopedic surgicalcase, operating room staff would be charged with the task of retrievingimplants and instruments 210, 510 requested by the surgeon. If theabove-mentioned screw 210, 510 was requested, the staff member wouldselect the screw 210, 510 from a list presented to the user on thedisplay. Once the item 210, 510 is selected, the software would searchthe database for related components and provide feedback on the properdrill bit, screw driver, and other components that are, or would likelybe, used with the screw 210, 510. The staff member could then select anyof the recommended components presented and be provided with thespecific slot location as well as a graphical representation of the itemlocation within the containment system. The information provided by thesoftware thereby allows the staff member to retrieve the items 210, 510,some of which not yet requested but needed by the surgeon, in anefficient, reliable, and accurate manner.

Over a period of time, item consumption information is accumulated inthe local database and transferred to the remote database through thecommunication means. The information is analyzed for usage trends ofboth specific items 210, 510 and item groups on a global basis (i.e.,all deployed automated CARTS), regional basis (within a specific entityor location), and CART-specific basis. Analysis of the trends isperformed to determine various usage analytics that provide the devicemanufacturer valuable information regarding inventory levels held withinan automated CART or at the specific hospital or surgery center toincrease supply chain efficiencies by influencing stocking andreplenishment. Items 210, 510 more frequently used can be stocked ingreater quantities while other, less used, items 210, 510 can be stockedin lesser quantities. Additionally, the consumption data across items210, 510 is analyzed to determine use correlations, thereby influencingsubsequent adjustments of on-hand quantities of related items andpredictive algorithms for supply chain planning to anticipate lowinventory levels and plan replenishments ahead of need and thus minimizethe risk of lacking a needed item at the time of surgery.

Additionally, item location data within the containment means correlatedwith usage trend data provide meaningful information regarding placementof items in the containment means. Continuing with the screw examplefrom above, items 210, 510 indicated as frequently utilized together andcorresponding location information about each, are analyzed to determineplacement of such items 210, 510 in close proximity, i.e., drawer and/orpackage slot location, within a compartment 110, 120, 130, 140, 310,320, 330, 340 to increase efficiency in retrieving the items 210, 510.On a larger scale, information on item usage and associated trends couldbe assimilated across automated CARTS located at different surgicalfacilities to provide more generalized product organization schema wherelocation-specific data is not available or adequate. The aggregatedusage data, both for individual items 210, 510 and groups, is alsoanalyzed to allow the manufacturer to adjust production quantities anddistribution strategies, thereby reducing overall inventory levels,providing rapid item replenishment, increasing working capital, andreducing overall operating cost.

In a preferred embodiment, the communication means is connected to theinternet and thus the remote server. User devices also connected to theinternet are thereby available to be connected to the remote server andany or all deployed automated CARTS. Many unique capabilities providedthrough utilization of schemes related to the internet of things (“JOT”)are contemplated through the connectivity of the automated CART.Specific to the above description, surgical staff may be connectedthrough the internet to portals allowing access to data residing on theremote server and any one or more automated CARTS. Likewise, userinformation may also be provided to the one or more automated CARTSand/or the remote server. In this regard, surgical schedules, routinelymaintained and communicated through the internet to the automated CARTor remote server, provide information on future surgical procedures andthe timing of thereof. This information is combined with surgical caseinformation, item use data and trends, and the like to assess andpredict, through the computational means of the local automated CART,the remote server, or the computational means of the user, inventorylevels required to support the surgeries. This predicted inventoryrequirement is then compared against inventory levels in the automatedCART or CARTs at the facility, nearby facilities, and/or globalwarehouses to determine and plan for item availability at the time andlocation of the future surgery.

In operation, the preferred surgical product supply system 100, which ispreferably a mobile system 100, is utilized to identify, collect andstore information regarding a plurality of surgical items 201 in themobile supply system 100. The preferred surgical product supply system100 includes a first compartment 110 having first and second RFIDantenna arrays 151, 152 mounted to first and second walls 110 a, 110 bof the first compartment 110. The system 100 preferably receives a firstplurality of surgical items 210 of the plurality of surgical items 201into the first compartment 110 wherein each of the first plurality ofsurgical items 201 is associated with an RFID tag 220 of a firstplurality of RFID tags 220. The first plurality of RFID tags 220includes a first RFID tag 220 associated with a first surgical item 210of the plurality of surgical items 201. Preferably, the RFID tags 220are associated with one of the packages 230 that are positioned withinthe first compartment 110 with different varieties of surgical items 210being positioned within the packages 230. The first and second antennaarrays 151, 152 are preferably utilized to scan the first plurality ofRFID tags 220 to determine a first RFID tag content information. Thefirst RFID tag content information is substantially comprised of adatabase of the first plurality of RFID tags 220, which can be utilizedto correlate to the packages 230 and surgical items 210 that are in thefirst compartment 110 during the snapshot of time when the firstcompartment 110 is scanned. The first RFID tag content information isthen transmitted to the local database and to the remote server 180 sothat the first RFID tag content information is saved and stored.Subsequently, the first compartment 110 is again scanned with the firstand second antenna arrays 151, 152 to determine a second RFID tagcontent information. The second RFID tag content information, similarly,provides a snapshot in time of the RFID tags 220 and, therefore, thepackages 230 and surgical items 210, that are in the first compartment.The second RFID tag content information is compared to the first RFIDtag content information to determine if the first RFID tag contentinformation is different than the second RFID tag content information.If there are RFID tags 220 in the second RFID tag content informationwhich were not in the first RFID tag content information, additional ornew packages 230 and surgical items 210 were added to the firstcompartment 110 between the first scan and the second scan. If there areRFID tags 220 in the first RFID tag content information that were not inthe second RFID tag content information, certain of the packages 230 andsurgical items 210 were consumed and the system 100 is able to identifywhich of the packages 230 and surgical items 210 were consumed so thatthe consumed packages 230 and surgical items 210 can be reordered andinserted into the first compartment 110. Each of the compartments 110,120, 130, 140 can be similarly scanned and analyzed to identify, collectand store information regarding the plurality of surgical items 201 andpackages 230 that are within the compartments 110, 120, 130, 140 at anyparticular time and to compare the RFID tag content information atdifferent times to track additions, consumption and replenishment of thepackages 230 and surgical items 201 associated with the system 100.

In the preferred embodiment, the product information, which ispreferably comprised of the packages 230 and surgical items 210 in thelocal database or the remote server 180 with the first RFID tag contentinformation to identify a first set of surgical products 210 that areassociated with the first plurality of surgical items. Accordingly, thesystem 100 is able to determine at any particular time which and howmany packages 230 and surgical items 210 are within the compartments110, 120, 130, 140 for use at the medical facility. The local databaseand the remote server 180 can communicate with various entities, such asbilling, sourcing, planning, third party suppliers and related entitiesto track and maintain inventories of surgical items 210 for anorganization, such as a hospital or surgical center.

The system 100 is also preferably able to determine a first consumedproduct set based on the comparison of the second RFID tag contentinformation and the first RFID tag content information, specificallywhen the comparison of the second RFID tag content information revealsthat there are less RFID tags 220 identified in the second RFID tagcontent information in comparison to the first RFID tag contentinformation. This preferably results in the system 100 identifying themissing RFID tags 220, which can be correlated to particular packages230 and surgical items 210, as consumed or used between the first scanand the second scan. The system 100 is also able to notify the remoteserver 180 of the first consumed product set and direct an inventorysystem to deliver a first replacement product set associated with thefirst consumed product set to the first compartment 110. The firstconsumed product set is preferably comprised of the consumed packages230 and surgical items 210 between the first scan and the second scan ormay include packages 230 and surgical items 210 that are identified bythe extra-compartment isolated consumption antenna 160 as beingconsumed.

The system 100 may further scan the first compartment 110 with the firstand second RFID antenna arrays 151, 152 to confirm the first pluralityof surgical items 201 are present in the first compartment. If there isno difference between the first RFID tag content information and thesecond RFID tag content information, such that all of the identifiedRFID tags 220 are the same at the two different time periods, the system100 determines that no packages 230 or surgical items 210 have beenconsumed and, similarly, no packages 230 or surgical items 210 have beenadded to the compartment 110, 120, 130, 140. The system 100 may alsodetermine, following at least two scans that newly added surgical items210 are in the compartment 110, 120, 130, 140 if the first RFID tagcontent information is different than the second RFID tag contentinformation by determining that more RFID tags 220 are in the secondRFID tag content information that are identified in the first RFID tagcontent information. The system 100 preferably stores newly added iteminformation related to the newly added surgical items 210 in the localdatabase and transmits the newly added item information to the remoteserver 180. The remote server 180 preferably identifies the newly addedsurgical items 210 and transmits the identified newly added surgicalitems 210 to the local database or may transmit an indication that thesurgical items 210 are unknown.

The system 100 may also receive, from the remote server 180, expirationdates for a first plurality of expiring surgical items 210 associatedwith the first plurality of surgical items 201 in response tocommunicating with the remote server 180, including item part numbersand item serial numbers related to the first plurality of expiringsurgical items 210. Such expiration dates are preferably tracked forsurgical items 210 that have a predefined shelf life and may also beutilized to identify surgical items 210 that are recalled or instruments210 that require refurbishment or repair following predetermined usage.

The system 100 may also determine a first consumed product set based onthe comparison of the second RFID tag content information and the firstRFID tag content information and create a consumption report based onthe first consumed product set. The consumption report can be utilizedby surgical or medical provider personnel to control inventory, plan forreplenishment programs, accounting and related tasks.

The preferred system 100 may also receive information related to asurgical procedure at the local database, preferably prior to conductingthe surgical procedure, identify a set of procedure specific surgicalitems 210 that are required to perform the surgical procedure anddisplay location information for the set of procedure specific surgicalitems 210 to the user or medical professional. The display of locationinformation may include identifying locations within the firstcompartment 110 where the set of procedure specific surgical items 210are stored in the first compartment so that the user is able to quicklyand easily obtain the procedure specific surgical items 210 during theprocedure or is readily able to plan for the procedure, includingsecuring surgical items 210 that the professional is aware are not inthe compartments 110, 120, 130, 140.

The preferred system 100 is able to monitor, at the remote server 180,the sensing, transmitting, scanning, comparing and determining steps toproduce usage data, usage trends, replenishment strategies,system-specific inventory and location groupings related to theplurality of surgical items 210.

The preferred system 100 receives, at the local database, surgicalschedules for a facility associated with the mobile supply system,predicts inventory levels of surgical items 210 in the compartments 110,120, 130, 140 required to support the surgical schedules, compares therequired inventory levels to the first plurality of surgical items 210and determines required surgical items 210 to support the surgicalschedules. This permits virtual planning for various surgical proceduresthat will be performed in the facility and may also factor proceduresthat are not specifically planned, but may occur based on historicalprocedure information.

The system, preferably at the local database or the remote server 180,may also determine if any of the RFID tags 220 identified in the secondRFID tag content information is different than a stored RFID tagcatalog. The stored RFID tag catalog is preferably stored in the localdatabase or the remote server 180 and includes a listing of all knownRFID tags 220 and associated packages 230 and surgical items 210. Thesystem 100 may request identifying information for any unknown RFID tag220 that is not listed in the stored RFID tag catalog.

The system 100 may in addition, receive, at the remote server 180, aconsumed RFID tag information from the extra-compartment isolatedconsumption antenna 160, to indicate that one of the first plurality ofRFID tags 220 was consumed. If surgical case information, i.e., surgeon,case number, user identification information, etc., is entered into thelocal database, this surgical case information is also communicated tothe remote server 180 in association with the first plurality of RFIDtags 220 consumed. The user preferably scans the RFID tag 220 at theextra-compartment isolated consumption antenna 160 after using thesurgical items 210 in the associated package 230 to confirm with thesystem 100 that the particular package 230 and associated surgical items210 were consumed and are no longer in the compartment 110, 120, 130,140.

The system 100 is also able to receive, at the remote server 180 or thelocal database, a consumed RFID tag identifier from theextra-compartment isolated consumption antenna 160 identifying aconsumed surgical item 210 and compare the consumed RFID tag identifierto the second RFID tag content information to determine if the consumedsurgical item 210 is identified in the second RFID tag contentinformation. The remote server 180 or the local database preferablyremoves the consumed surgical item 210 from the second RFID tag contentinformation if the consumed surgical item 210 is identified in thesecond RFID tag content information. In addition, the remote server 180or the local database preferably sends a signal indicating that theconsumed surgical item 210 was consumed if the comparison of theconsumed RFID tag identifier to the second RFID tag content reveals theconsumed RFID tag identifier is not included in the second RFID tagcontents.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but isintended to cover modifications within the spirit and scope of thepresent invention as defined by the present disclosure.

1-20. (canceled)
 21. A mobile surgical product supply system forstoring, identifying, and tracking a plurality of surgical equipment andsupplies, the supply system comprising: a radio frequency-isolatedcompartment configured to store the plurality of surgical equipment andsupplies, the radio frequency-isolated compartment includes first,second, third and fourth walls, a storage area defined by the first,second, third and fourth walls, the first wall defining a first wallplane and the second wall defining a second wall plane, the first andsecond wall planes spaced apart at a first antenna array distance thatis less than thirty-six inches, the plurality of surgical equipment andsupplies including a first surgical item and a second surgical item, thefirst surgical item associated with a first RFID tag and a first packageand the second surgical item associated with a second RFID tag and asecond package, the plurality of surgical equipment and suppliespositioned in a plurality of RFID tagged packages, the plurality of RFIDtagged packages including the first package with the first RFID tag andthe first surgical item and the second package with the second RFID tagand the second surgical item, a plurality of RFID tags including thefirst and second RFID tags, the plurality of RFID tagged packagesincluding a plurality of proximate RFID tagged packages, the radiofrequency-isolated compartment has a total internal volume no greaterthan seven cubic feet; first and second RFID antenna arrays configuredto scan the plurality of surgical equipment and supplies within thecompartment, the first antenna array attached to the first wall andincluding a first RFID antenna and a second RFID antenna, the secondantenna array attached to the second wall and including a third RFIDantenna and a fourth RFID antenna; and an RFID reader in communicationwith the first and second RFID antenna arrays, the RFID readerconfigured for controlling the first and second RFID antenna arrays toperiodically scan the plurality of RFID tagged packages to determine afirst number of the plurality of RFID tagged packages that are in theradio frequency-isolated compartment.
 22. The supply system of claim 21,wherein the plurality of proximate RFID tagged packages comprise atleast forty percent of the plurality of RFID tagged packages, theplurality of proximate RFID tagged packages positioned within fourinches of the first and second wall planes.
 23. The supply system ofclaim 21, wherein each of the plurality of RFID tags includes an RFIDtag surface comprising a plurality of RFID tag surfaces, at least eightypercent of the plurality of RFID tag surfaces oriented substantiallyparallel to a vertical plane, the vertical plane oriented substantiallyorthogonal to the first and second wall planes.
 24. The supply system ofclaim 21, wherein the first antenna array distance is no greater thaneighteen inches, thereby separating the first antenna arrayapproximately no greater than eighteen inches from the second antennaarray.
 25. The supply system of claim 21, wherein a ratio of combinedantenna-mounting surface area is comprised of a surface area of thefirst wall relative to a surface area of the first RFID antenna array isno greater than four.
 26. The supply system of claim 21, wherein theradio frequency-isolated compartment includes a rear wall and a frontwall.
 27. The supply system of claim 21, wherein a ratio of a totalcombined six side surface areas is comprised of a combined side surfacearea of the first, second, third, fourth, front and rear walls relativeto a surface area of the first and second RFID antenna arrays is nogreater than twelve.
 28. The supply system of claim 21, furthercomprising: a containment drawer movably mounted to the radiofrequency-isolated compartment, the containment drawer having an outwardface, the outward face containing a radio frequency-absorptive, a radiofrequency-reflective or a combination of radio frequency-absorptive andradio frequency-reflective material.
 29. The supply system of claim 21,wherein the radio frequency-isolated compartment has a tagged packagedensity, the tagged package density being no less than eighty-five tagsof the plurality of RFID tags per cubic foot.